JP2002523153A - Fixation systems such as catheters - Google Patents

Abstract

An anchoring system includes a simply-structured device which permits a portion of a catheter or similar medical article to be easily anchored to a patient, desirably without the use of tape or needles and suturing. The anchoring system desirably includes a retainer and an anchor pad. The retainer is sized and configured to accept and retain a section of a catheter within the anchoring system and desirably includes a pair of posts and a clip. The posts are sized and configured to releasably accept holes formed in the catheter or the catheter fitting. The clip is sized and configured to releasably accept a portion of the catheter. The anchor pad secures the retainer to a patient's skin.

Description

DETAILED DESCRIPTION OF THE INVENTION

FIELD OF THE INVENTION The present invention relates generally to a fixation system for securing a medical article to a patient, and more particularly, to a catheter or other elongate catheter that does not move or slip from the patient. The present invention relates to a fixation system for fixing a medical article to a patient.

BACKGROUND OF THE INVENTION When treating a patient, it is very common to utilize catheters to introduce fluids and drugs directly into the patient, or to withdraw fluid from the patient. For example, one catheter utilized to introduce fluid to a patient is a midline catheter.

In most cases, catheters remain in place for days or weeks. To secure the catheter in place at the insertion site, health care providers often use tape to secure the catheter to the patient. That is, a health care provider typically applies a long section of tape in a cross shape across a portion of the catheter near the insertion site to secure the catheter to the patient's skin. This fixation prevents the catheter from moving from its insertion site and prevents the catheter from becoming entangled with the handrails or other objects in the bed.

[0004] However, tapes are often contaminated with dirt and other contaminants. Therefore, standard protocols require that the tape be changed regularly (eg, daily) to prevent the growth of bacteria and microorganisms at the fixation site. However, frequent tape changes pose the problem of exfoliation of the patient's skin. In addition, valuable time is spent applying and reapplying the tape. In addition, many providers often remove the gloves when taping because they find the taping procedure when using latex gloves to be difficult and cumbersome. This not only prolongs the taping procedure, but can also infect health care providers. Furthermore, even if the healthcare provider remains gloved,
Contact between the adhesive surface of the tape and the latex glove creates microscopic holes in the glove that can infect health care providers.

As an alternative to tape fixation, some catheters include clamps with integral or movable, flexible, winged extensions. These extensions are sutured to the patient's skin to secure the catheter in place at the insertion site. In other applications, a flexible clamp is covered with a rigid box clamp and receives a catheter / clamp combination by friction fitting. The box and flexible clamps have holes arranged in a lateral direction, which allows the combination to be sutured to the patient's skin. Although this technique securely attaches the catheter to the patient, it is apparent that the patient is painful and uncomfortable. This conventional retention technique is also time consuming and inconvenient, creating the risk of the needle sticking to the health care provider and the risk of infecting the patient from the suture site.

In addition, suture materials tend to provide poor grip on medical tubing and can pass through the winged extensions of flexible clamps when rigid clamps are not used. However, the use of rigid clamps complicates the securing procedure by adding additional components and can drop to the floor and become non-sterile. Moreover, suturing with a flexible clamp or a combination of flexible / rigid clamps does not allow the catheter to be easily removed from the patient for bandage replacement and cleaning of the insertion site.

SUMMARY OF THE INVENTION One aspect of the present invention comprises a simple structured fixation system that secures an elongated medical article (eg, a catheter) in a fixed position relative to an insertion site. At the same time, it prevents the medical article from being pulled while facilitating the planned removal of the medical article from the fixation system for dressing changes or other tasks. It is not necessary to use tools such as hemostats or surgical clamps to remove the medical article from the fixation system.

[0008] One form of the anchoring system comprises an anchoring pad having a first side and a second side. The second surface includes an adhesive layer covering at least a part of the second surface. A holding device is attached to the first surface of the fixation pad to support a portion of the medical article. The retaining device includes a base mounted on the first surface and at least one post extending from the base. The post has a fixed portion located towards the outer end of the post. There is also at least one clip on this holding device. The clip is sized and shaped to fit at least a portion of the medical article.

[0009] Another aspect of the invention comprises an anchoring system for anchoring an elongated medical article to a patient. The medical article has at least one opening. The securing system includes a securing pad and a holding device attached to the securing pad. The holding device is
A first holding member disposed substantially upright with respect to the fixed pad; The first holding member is configured to be inserted into a corresponding opening of the medical article. The holding device also includes a second holding member connected to the fixed pad. At least a portion of the second holding member is disposed substantially at right angles to the first holding member, and at least a portion of the elongated medical article is attached to a portion of the second holding member and the fixation pad. Are spaced apart from the fixed pad by a dimension sized to allow placement between them.

According to another aspect of the present invention, there is provided a method of securing a medical article to a patient's body, the medical article comprising an elongated body with flexible wings extending from the body. Each of these blades has at least one suture hole. The method provides a holding device having at least first and second posts spaced apart. The clip of the holding device is located on the side of the post. The first post is inserted into one of the suture holes of the flexible wing of the medical article. The flexible wing is extended so that another suture hole is positioned on the second post. The stretched wing is then hooked onto the second post, thereby inserting the second post into the corresponding suture hole. A portion of the elongate body is inserted into and disposed within the clip, such that the elongate body is prevented from detaching from the clip. In a preferred form, the holding device is adhered to the patient's body.

[0011] Other aspects, features and advantages of the present invention will become apparent from the following detailed description of the preferred embodiments.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION The above and other features of the present invention will now be described with reference to the drawings of preferred embodiments of the fixation system of the present invention. The illustrated embodiment of the fixation system is for purposes of illustration and not limitation.

[0013] Embodiments of the present invention relating to a fixation system for medical articles are disclosed with respect to an exemplary midline catheter. However, the principles of the present invention are not limited to median catheters. Rather, in light of the present disclosure, the fixation systems and retention devices disclosed herein have been successfully used with other types of medical articles, including other types of catheters, fluid drainage and delivery tubes, and electrical wires. Those of skill in the art will also appreciate the availability. For example, the retention devices disclosed herein include central venous catheters, peripheral catheters, peripherally inserted central catheters, hemodialysis catheters, surgical drainage tubes, feeding tubes, thoracic tubes, nasal feeding tubes, speculum, and It can also be configured to receive and secure wires or cables connected to external or embedded electronic devices or sensors, these devices being one-piece with one or more securing openings. Alternatively, it is assumed that a movable attachment (for example, an attachment with a blade) is provided, but the holding device of the present invention is not limited to these. One skilled in the art can also find additional applications for the devices and systems disclosed herein. Therefore,
The illustration and description of a fixation system for a midline catheter is merely illustrative of one possible application of the fixation system. The catheter of the illustrated embodiment comprises:
At least a flexible or deformable winged fitting made of silicone or latex. An exemplary midline catheter is made of silicone for both the catheter body and the winged fitting, Sandy, Utah
Commercially available from Becton, Dickinson and Company.

The embodiments described herein use several basic concepts that are unique to the fixation system, namely, the concept of removably engaging a medical article with a patient.
Removable engagement is provided by the cooperation of the post, clip, and catheter fitting elements. This cooperation allows the catheter to be removed from the fixation system and the patient for any of a variety of known purposes. For example, a health care provider may want to remove the catheter from the fixation system to facilitate removal of the catheter from the point of insertion or to clean the patient.
However, removal of the catheter from the fixation system can be achieved without removing the fixation system from the patient. Moreover, the removal of the catheter can be performed without breaking the fixation system, for example, without using tools such as hemostats or surgical clamps.

Embodiments described herein also prevent the catheter from moving axially and not rotating relative to the fixation system. Axial movement is counteracted by a retaining effect, typically provided by a post cooperating with a hole in the vaned catheter fitting. Rotational motion is counteracted by the retaining effect typically provided by clips that cooperate with the posts, and prevents movement of the catheter that would otherwise rock or rotate the catheter fitting, causing it to slip or slip out of engagement with the post. Hinder.

To assist in describing these components of the fixation system 10, the following associated terms are used. The “vertical axis” is generally parallel to the catheter 12 held by the fixation system 10. The “horizontal axis” is perpendicular to the vertical axis and is substantially parallel to the plane of the fixed pad 56. The "cross axis" extends at right angles to both the vertical and horizontal axes. Further, as used herein, "vertical direction" refers to a direction substantially parallel to the vertical axis, "horizontal direction" refers to a direction substantially parallel to the horizontal axis, and "cross-axis direction" refers to a direction substantially parallel to the cross axis. Point in a direction parallel to the top. Also, the terms "proximal" and "distal" used in describing the fixation system 10 of the present invention are used consistently in describing the exemplary application. Thus, proximal and distal are used relative to the center of the patient's body. next,
The fixation system 10 and its associated use will be described in detail.

Referring initially to FIGS. 1 and 2, a fixation system 10 is shown and is constructed in accordance with a preferred embodiment of the present invention. This system includes the holding device 20 and the fixing pad 56. The holding device 20 is fixed to the patient's skin by the fixing pad 56. The securing pad 56 has a lower adhesive surface 58 that adheres to the patient's skin and an upper surface 62 that supports and secures the holding device 20.

The retaining device 20 is sized and shaped to receive and retain a portion of the catheter 12 within the fixation system 10 (FIGS. 6-8). The holding device preferably includes at least a first holding member and a second holding member. The first retaining member is disposed generally upright with respect to the fixation pad 56 and is configured to pass through a corresponding opening 74 (eg, a suture hole) of the catheter fixture 14. The first retaining member is configured to engage a portion of the catheter fitting 14 at the opening 74 such that the catheter 12 does not inadvertently disengage from the first retaining member. The second holding member is connected to the fixing pad 56. Second
At least a portion of the holding member is disposed so as to be substantially perpendicular to the first holding member, and at least a portion of the catheter 12 is disposed between a portion of the second holding member and the fixing pad 56. In order to be able to do so, it is arranged at a sufficient distance from the fixing pad 56. Further, the second holding member is configured such that the supported portion of the catheter 12 is the second holding member.
Is configured not to be pulled out of the engagement state with the holding member.

In the embodiment shown, the first holding member preferably comprises a post 30 and the second holding member preferably comprises a clip 48. The holding device 20 includes a pair of posts 30 and clips 48 arranged on the sides of the posts 30.
More preferably, the holding device 20 will be understood by those skilled in the art.
Can be any combination of posts and clips to suit a particular application. For example, the retaining device 20 can include a post 30 disposed between a pair of clips 48 on the retaining device. This post 30 is
Alternatively, it is sized and shaped to removably receive a hole 74 formed in the winged catheter fitting 14. Clip 48 is sized and shaped to removably receive a portion of catheter 12.

Referring to FIG. 2a, the holding device 20 has a rigid structure formed mainly by the base 22. In the embodiment shown, the base 22 is integrally formed with the post 30 and the clip 48 to form the holding device 20 by itself. This configuration,
It can be implemented in any of a variety of ways known to those skilled in the art. For example, the entire holding device 20 can be injection molded to reduce manufacturing costs.

In addition, as will be apparent from the description below, some features of the retainer 20 (eg, the clip, and to some extent the post and the retainer itself) are desirably flexible. Suitable materials that are rigid and flexible include, for example, polypropylene, polyethylene, polycarbonate, polyvinyl chloride, acrylonitrile butadiene styrene, nylon, olefins, acrylics, polyesters, as well as silicone for molding, thermoplastic urethane, heat Examples include, but are not limited to, plastics, polymers, and composites, such as plastic elastomers and thermosets. The illustrated holding device 20 is preferably formed by injection molding using a plastic or polymer material. However, other materials can be utilized, and the retaining device 20 can consist of a non-integral base, post, and / or clip.

As can be seen in FIG. 2 a, the base 22 has a vertical (XX) and a horizontal (Y
-Y) comprising an elongate body formed substantially along a plane lying within. Base 22 has a distal end 24 and a proximal end 25. The base 22 can be formed in a wide variety of shapes, such as a square, circle, triangle, curve, etc., to suit a particular application. For example, the base 22 can be configured to resemble the shape of the fixed pad 56. The illustrated embodiment shows a generally elliptical base including first and second sides 26,28.

The longitudinal dimension of the base 22 is desirably long enough to provide stability to the catheter 12 along its length. That is, the held catheter 1
The length of the two portions is sufficient to prevent the catheter 12 from swinging relative to the holding device 20 (ie, so that the holding device 20 does not serve as a fulcrum for the catheter 12). This is preferably also true for the lateral dimensions of the holding device 20. Further, the lateral dimensions of the base 22 are such that a healthcare provider can easily and naturally grip the holding device 20 and provide space for one or more posts and one or more clips to be placed. It is desirable to have.

Referring now to FIGS. 2 a, 3 a, and 4 a, one or more posts 30 extend from base 22. The illustrated embodiment includes two posts 30 that extend substantially upright with respect to the base 22. However, the base 22 may include additional posts 30 to suit a particular application. For example, the holding device 20
If is designed to secure a relatively large catheter 12 or catheter fitting 14, the base 22 may be provided with four posts located in rectangular corners for added stability. it can. Also, three posts can be used to securely fix the Y-site fixture.

Each post 20 includes a shank or shank 32 attached to and extending from the base 22. Shaft 32 may be of various lengths and may be of various distances depending on the particular application and to allow the interaction of a particular fitting 14 with catheter 12 to be mounted. . To secure the catheter and the medical tubing, the length of each shaft 32 is desirably about 2 mm to 20 mm, more preferably 4 mm, but a longer shaft or a shorter shaft. It is also possible to make a division. Shafts 32 are spaced laterally wide enough to accommodate at least the catheter to be secured, and in the illustrated embodiment, shafts 32 can accommodate fittings 14 that secure catheter 12. , Are arranged at intervals. Preferably, the shaft 32 is positioned on the holding device 20 at a distance slightly greater than the distance between the corresponding suturing holes 74. For many applications, the distance between the posts 30 will be between 5 mm and 40 mm, and more preferably will generally be equal to about 20 mm. Shaft 32 of each post 30
Has a diameter sufficient to perform its structural function, as described in more detail below, and depends on the materials selected for base 22 and post 30. The illustrated post 30 is comprised of a plastic or polymer material having a diameter between 0.5 mm and 5 mm, especially about 2 mm.

In addition to the cylindrical shape shown in the illustrated embodiment, it is contemplated that the shaft portion 32 can be formed in any of a variety of elongated shapes, such as a square or triangle, to suit a particular application. As will be described in greater detail below, the elongated shape of the shaft 32
Generally, it is preferable to match the shape of the hole 74 in the catheter fitting 14.

The shaft portion 32 has a fixed portion that prevents the displacement of the catheter 12 and the catheter fixture 14. This fixed portion may include one or more of the elements described below.

One element of the fixed portion is formed by a projection extending in the radial direction from the shaft portion 32. As shown in FIGS. 2a, 3a, and 4a, the protrusion includes an enlarged tip or head 34 at an end distal from the base 22. It is desirable that at least a part of the outer periphery of the head 34 is longer than the outer periphery of the shaft portion 32, and the maximum outer periphery is 1.1 to 3 times the outer periphery of the shaft portion 32. FIG. 2a shows a generally hemispherical head 34 with a smooth surface, with the outer periphery at the overhanging lower surface or back surface 36 being maximal. However, the head 34 has a back surface 36, such as a solid cone or hollow cone, arrowhead, barbed, spherical, truss, or other type of radially protruding structure,
It will be appreciated that, alternatively, various other shapes without backside 36 may be employed. The head 34 preferably does not become entangled with materials such as the provider's latex gloves or patient bed sheets due to its relatively blunt end 37.

As seen in FIGS. 2a, 3a, and 4a, the back surface 36 is generally planar. However, the back surface 36 can be curved to form a recess 38 that can hold a portion of the catheter fitting 14. The back surface 36 may be a roughened surface or a surface incorporating a ridge or other snagging device (not shown), which may further assist in retaining the catheter fitting 14. it can. However, the back surface 36 may be smooth to reduce manufacturing costs.

Another element of the fixed part is constituted by a hook 40. As shown in FIGS. 2 b, 3 b, and 4 b, the hook 40 includes a radial portion 4
2 The hook 40 preferably has a curved portion 44 distal from the shaft 32 and toward the distal end of the radial portion 44. The curved portion 42 is sized and shaped to receive a hole in a catheter fitting. The curved portion 42 preferably has a chamfer or taper 46 along the distal circumference so that a healthcare professional can easily fit the hole 74 in the catheter fitting 14 to the hook 40.

Referring now to FIGS. 1, 2 a, and 3 a, clips 4 are generally mounted on base 22.
8 are formed. The illustrated embodiment shows one clip 48 extending from the base 22. However, the base 22 can also include additional clips as described above to suit a particular application. For example, if the holding device 20 is designed to secure a relatively large catheter, to increase stability,
The base may include two clips located at opposite ends of the catheter. Also, three clips can be used to secure the Y-shaped catheter.

The clip 48 is sized and shaped so as to easily receive a portion of the catheter 12 while preventing the receiving portion of the catheter 12 from easily detaching. ing. The clip 48 preferably prevents at least a portion of the catheter 12 from moving in the transverse direction. Catheter 12
Is prevented by contact with clip 48, which is of sufficiently rigid construction and is secured to base 22 so that catheter 12 does not advance in the axial direction. To act as a stopper. The transverse movement of the catheter is controlled by the movement of the catheter 12 (or the catheter fixture 14).
It is advantageous to prevent this catheter from moving in the axial direction, as this could translate into movement of the catheter 12 at the site of engagement of the post 30. This movement may also cause the catheter fitting 14 to roll or slip off of the post 30 and out of engagement with the post 30.

The clip 48 can be configured in various ways to achieve its purpose. FIG. 2a shows a substantially C-shaped clip with a catheter 1 therein.
Part of 2 is captured. FIG. 2b shows a pair of semi-rigid inverted L-shaped members that are spaced apart to removably receive a catheter 12 that is larger than the gap between the members. They are located close together. As will be appreciated by those skilled in the art, various other configurations of clips, such as a single L-shaped clip, may be used to accomplish the purpose of this clip.

The clip 48 can include the hook portion 52 described above, or can include a variety of other entangled, hooking, and inhibiting devices as described above. The clip 48 can be of various sizes depending on the particular application and the particular catheter 12 used with the clip.

In the illustrated embodiment, the clips 48 are positioned on a vertically extending line that approximately bisects a lateral extension extending between the two posts 30. An area 54 is formed laterally between the first and second sides on the holding device, preferably between the posts 30. The area 54 is sized and shaped to receive and retain a portion of the catheter 12 such that the portion of the catheter 12 fits snugly between the post 30 and the clip 48. .

FIG. 1 shows a fixed pad 56, which is composed of an upper foam layer (
For example, a laminated structure having a closed-cell polyurethane foam) and a lower adhesive layer is desirable. The lower adhesive layer forms the lower surface 58 of the fixing pad 56. This lower surface 58 is desirably a medical adhesive and may or may not be a sweating agent, depending on the particular application. Such foams having an adhesive layer are available from New Dimensions in Medicine in Columbia, Ohio.
e. The embodiment shown illustrates a securing pad 58 having a suture hole 60 in addition to an adhesive layer to further secure the securing pad 56 to the patient's skin.
Is shown. However, it will be appreciated that the fixation pad 56 may not include a suture hole 60 for securing the fixation pad to the patient's skin.

The surface of the upper foam layer forms the upper surface 62 of the fixing pad 56. The upper surface 62 is preferably roughened by corona treating the foam with a low charge. The roughened or porous top surface 62 improves the quality of the adhesive bond between base 22 and securing pad 56 (described below). In an alternative example, the flexible securing pad 56
May comprise a medical adhesive lower layer, an inner foam layer, and an upper paper layer or other upper woven or non-woven layer.

In the illustrated embodiment, the securing pad 56 includes a pair of opposing crescents 64,
Preferably, a recess 66 is provided, the recess of which is towards the proximal end 24 of the securing pad 56 closest to the clip 48. As a result, the sides of the fixation pad 56 contact the patient's skin over a larger area, providing greater stability and adhesion.

FIG. 5 shows a removable paper or plastic release liner 68, which desirably covers the adhesive lower surface 58 before use. Preferably, the liner 68 is resistant to tearing, and is preferably divided into a plurality of pieces and the pad is easily attached to the patient's skin. In the illustrated embodiment, the liner 68 is split along the centerline 70 of the flexible securing pad 56 so that only one half of the adhesive lower surface 58 is exposed at one time.

The length of the liner 68 extends beyond the centerline 70 of the fixed pad 56 and is folded or folded over the liner 68. The folded portion constitutes a pull tab 71 for facilitating removal of the liner 68 from the bonding lower surface 58. The medical worker pulls the liner 68 away from the lower surface 58 by grasping and pulling the pull tab 71. Pull tab 71 overcomes any requirement that a healthcare professional pull on a corner edge or other segment of liner 68 to separate liner 68 from the adhesive layer. Of course, the pull tab 71 can be designed in various shapes. For example, the pull tab 71 need not be located along the centerline 70 of the fixation pad 56, but rather the pull tab 71 may be positioned on any of the fixation pads 56 to facilitate attachment of the fixation pad 56 to a particular area of the patient's skin. Along the line or portion. For example, in areas of the patient's skin with sharp bends, such as joints, it may be necessary to align the pull tab 71 toward one of the side edges of the fixation pad 56 rather than along the centerline 70. is there.

The base 22 of the holding device 20 is attached to the upper surface 62 of the fixing pad 56.
The base 22 is preferably secured to the upper surface 62 by a solvent bonding adhesive such as cyanoacrylate or other bonding material. One such adhesive is the
Minnesota Mining and Manufacturing C
mpany (3M) to Part No. 4693.

When assembling the fixation system 10 as described above, the area 54 formed on the base 22 constitutes a receiving space 72. The receiving space 72 can receive a portion of the length of the catheter 12. The receiving space 72 can have various shapes depending on the application (i.e., depending on the shape of the part where the medical device is to be held and the holding device 20 is designed to be used therein). Although possible, the receiving space 72 is of sufficient length in the longitudinal direction to stabilize the catheter 12, but not to serve as a fulcrum for the catheter 12 as described above. That is, the vertical gap between the post 30 and the clip 48 on the retainer 20 is sufficient to allow the catheter 12 to cross-, longitudinally and cross- It is dimensioned so that it does not move in the direction (i.e., the roll, pitch and axial movement of the catheter 12 is prevented).

When the catheter fitting 14 is placed on the post 30 via the hole 74 and pressed onto the receiving space 72, a portion of the catheter 12 is captured in the holding device 20. The catheter fitting 14 is made of a material that is more resilient than the holding device 20, and the distance between the posts 30 is desirably slightly greater than the distance between the holes 74 in the catheter fitting 14. In accordance with this design, in order to fit the catheter fitting hole 74 to the post 30, when the catheter fitting 14 is extended, a pulling force is applied to the catheter fitting 14 and the post 30 and the catheter fitting 1 are pulled.
4 creates an interference fit such that the catheter 12 does not move axially and does not rotate. Rotational movement of the catheter 12 is further prevented by the clip 30 as described above.

In operation, as shown in FIGS. 6-8, a medical practitioner attaches the catheter 12 (or other medical article) using the fixation system described above (or an easily understood variant thereof). Can be fixed to the patient. The healthcare professional first aligns hole 74 of catheter fitting 14 above post 30 on the transverse axis. The post 30 is then engaged with the hole 74 in the catheter
The catheter 12 is placed in the receiving space 72 formed between the two sides. This involves first inserting the first post into one of the suturing holes 74 and then stretching the fitting 14 to place another suturing hole 74 into the second post, as seen in FIG. This is done by aligning on top of 30. The fixture 14 is then slid over the second post 30 by inserting the post 30 into the hole 74. In this manner, the catheter fitting 14 is hooked on the lower surface 36 of the post 30. The interaction of the back surface 36 of the post 30 with the portion of the fitting 14 near the suturing hole 74 prevents the catheter fitting from coming off the post 30 in the axial direction. The overall interaction between post 30 and fixture 14 causes catheter 12 to be significantly (ie, significantly) longitudinally and laterally relative to retaining device 20.
Stuck.

As seen in FIG. 8, the distal portion of catheter 12 is inserted into clamp 48 by positioning catheter 12 next to the opening of clip 48 and drawing catheter 12 into clip 48. The deformable nature of the catheter 12 and / or the flexibility of the clip 48 allows a portion of the catheter to be inserted into at least the space between the portion of the clip 48 and the base 22.
It is important that a portion of the clip 48 extend generally parallel to the base 22 and perpendicular to the post 30. In this portion of the clip 48, the unsecured catheter 12 is secured beneath the clip 48 as the fixture is removed axially from the retaining device.
Of the catheter fitting 14 is prevented from being subjected to transverse forces. This design allows greater transverse forces to be applied to the catheter before disengagement from the retainer than without clip 48.

When the catheter 12 is pulled in the axial or rotational direction, the interaction of the post 30, clip 48, and catheter fitting 14 causes the catheter 1
2 is prevented from moving appreciably. Thus, the retaining device 20 prevents the catheter 12 from moving axially or rotating relative to the retaining device 20.

It is important that the posts 30 and clips 48 do not shrink or twist the body of the catheter 12 when the catheter 12 is inserted into the receiving space 72. Further, the posts 30 and clips 48 compress the catheter, but the pressure is limited and does not occlude the corresponding catheter 12 lumen. FIG.
Shows the gap between the anchoring portion 34 of the post 30 and the catheter fixture 14, but the stem 32 of the post 30 when secured, cross-axially of the catheter fixture within the fastening system. Can be dimensioned for a particular catheter fixture 14 such that the amount of play is reduced.

FIGS. 9 and 10 show a fixation system constructed according to another embodiment of the present invention. Like the fastening system of the previous embodiment, the fastening system comprises a holding device having at least one holding member and a fastening pad. However, the specific configuration of these elements is slightly different. Also, the specific configuration of the medical articles connected to the fixation system is different. Therefore, for the sake of consistency, like numbers with "a" added are used to indicate like parts of the fixation system of FIGS. Thus, it should be understood that the above description of like components applies equally to this embodiment of the fixation system 10a unless otherwise indicated.

Referring to FIG. 9, the illustrated catheter fitting 14a is constructed entirely of silicone material for flexibility, so that the laterally extending wing portion 13a of the fitting 14a The provided pair of holes 74a expands during a connection operation or a disconnection operation. The catheter fitting 14a is connected to the catheter 12a.
Has an elongated body with a lumen for accommodating it, and can be attached to a plastic connecting piece 10. An exemplary midline catheter 12a is a B-type, Sandy, Utah.
Ecton, Dickinson and Company from First M
It is commercially available as id-Cath ^™ .

As in the previous embodiment, the holding device 20a is configured to receive a portion of the catheter fitting 14a and to provide a space in which at least one holding member is located, and have dimensions and shapes. It is determined and formed.

Referring to FIG. 10, the first holding member includes two laterally spaced apart holding members.
Although it is desirable to have a number of posts 30a, one or more posts can be used. Each post 30a includes a shank or shank 32a attached to and extending generally upright from the base 22a. Each shaft portion 32a has a length of about 2 mm to 20 mm, preferably 4 mm, and 5 mm to 4 mm each other.
They are arranged laterally at a distance of 0 mm, preferably at a distance of about 20 mm. The shaft portion 32a of each post 30a has a diameter sufficient to perform its structural function, and in the case of the illustrated shaft portion 32a, the diameter is 0.1 mm.
It is between 5 mm and 5 mm, preferably about 2 mm.

The shaft portion 32a can include a fixing portion that prevents the catheter 12a and the catheter fitting 14a from being displaced from the shaft portion 32a. If used,
The securing portion can include one or more elements as described above or below. Alternatively, the shaft portion 32a may not have a fixed portion for assisting a connection operation or a detachment operation, as described below.

One element included in the fixed portion is a protrusion that extends radially outward from the end of the shank 32a distal to the base 22a. As best shown in FIG. 10A,
The protrusion is a generally smoothly angled enlarged tip or head 34a having a back surface 36a that extends radially in all directions about the shank 32a. However, the head 34a may be, for example, a solid cone or a hollow cone,
It can take a variety of other shapes with or without the back surface 36a or portions thereof, such as barbed, barbed, spherical, trussed, hemispherical, and other types of radially protruding structures. Will be understood. The relatively blunt end 37a of the head 34a preferably prevents entanglement with materials such as healthcare provider latex gloves and patient bed sheets. Alternatively, the head 34
Preferably, the relatively rounded end 100 of a assists in aligning hole 74a on head 34a. At least one of the heads 34a may optionally include an extension 102 angled in a direction opposite to the other post 30a. The angled portion 102 includes the catheter fitting 14a
Sized and shaped to receive a hole 74a of the catheter fitting 14a along the outer end to more easily align the hole 74a of the catheter fitting 14a around the angled portion 102. It is desirable to have a chamfer or taper 46a. When the hole 74a is aligned with the angled portion 102, the hole 74a
a is advanced / stretched along the head 34a onto the shaft 32a.

Another element provided by the anchoring portion is a projection that extends radially outward from the end of the shank 32a, also distal to the base 22a. As shown in FIG. 10B, the protrusion is a generally smooth, rounded enlarged tip or bulb 104,
Including those without a back side. However, it is also possible to use a back surface that extends radially around the entire length of the shaft 32a or a portion thereof. Preferably, the relatively blunt end 106 of the bulb 104 prevents it from tangling with materials such as the provider's latex gloves or patient bed sheets. Alternatively, the spherical portion 104
Preferably, the relatively rounded end 108 helps to align the hole 74a with the spherical portion 104. The bulb 104 may optionally include an extension 110 that is curved in a direction opposite to the other post 30a. The curved portion 110 is sized and shaped to receive the hole 74a of the catheter fitting 14a.
It is desirable to have a chamfer or taper 46a along the free end to more easily align the hole 74a of 4a. Once the hole 74a is aligned with the curved portion 110, the hole 74a can be advanced around the bulb 104 onto the shaft 32a.

[0055] Both shaft portions 32a need not necessarily include the fixed portion as described above. If no securing portion is used, the end of the shank 32a distal to the base 22a desirably has a smooth, slightly rounded surface. This shape assists in aligning the hole 74a of the catheter fitting 14a with the shaft 32a. This shape (
(Not shown) provides easier engagement of hole 74a with shaft 32a (ie, hole 74a need not be further expanded to fit over head 34a or bulb 104), but both. The use of the fixed portion 34a on the shaft 32a increases the safety of the catheter fitting 14a on the retaining device 20a.

Referring again to FIG. 10, the second securing member includes a clip 48a extending from the base 22a. As in the previous embodiment, the clip 48a easily receives a portion of the catheter fitting 14a or a portion of the catheter 12a, and prevents the catheter fitting 14a or the receiving portion of the catheter 12a from easily detaching. The size and shape are determined. Advantageously, clip 48 also prevents transverse movement of at least a portion of catheter mount 14a.

The clip 48a can be configured in various ways to achieve its purpose. For example, FIG. 10A illustrates a clip 48a that is generally C-shaped and configured generally similar to the clip of FIG. 2A. However, this embodiment of the clip 48a has a larger and more clearly defined hook portion 52a extending toward the base 22a, narrowing the entrance 112 to the clip interior 114,
Or it is partially closed. Because of the narrowed inlet 112, the healthcare professional may flatten or otherwise distort a portion of the catheter fitting 14a as the catheter is passed through the inlet 112 and into the clip interior 114. is necessary. Once a portion of the catheter fitting 14a is positioned within the clip 114, the inlet 112 is narrowed so that the portion of the catheter fitting 14a is flattened or otherwise distorted before the clip It is necessary to push the catheter fitting 14a out of 114. This arrangement prevents the catheter fitting 14a from being accidentally pushed out of the clip interior 114. In particular, the axial height of the illustrated narrowed inlet 112 is less than three-quarters of the axial height of the catheter fitting 14a, preferably the catheter 1
2a, less than half the axial height, more preferably the catheter fitting 1
4a is about one half of the axial height. In other words, when used with the illustrated catheter fitting 14a, the narrowed inlet 112 has an axial height of about 1 m.
m to 5 mm, preferably about 3 mm.

As another example, FIG. 10B illustrates a clip 48a having a generally inverted L-shape.
1 shows a clip formed substantially in the same manner as the clip of FIG. However, this embodiment of clip 48a does not include any hook portions. Therefore, the entrance 112 to the clip interior 114 is not narrowed and is not partially occluded, so that the catheter fitting 14a can be easily inserted or removed from the clip interior 114. In particular, the axial height of clip 48a is the same as or slightly higher than the axial height of catheter fitting 14a, or about 3-10 mm when used with the illustrated catheter fitting, and preferably about 3-10 mm. It is about 6 mm.

FIG. 9 shows an upper foam layer 62 a, a lower adhesive layer 58 a, and these layers 58 a
1, a fixing pad 56a including a laminated structure having a suturing hole 60a formed therethrough and formed in the same manner as the fixing pad of FIG. The particular shape of the fixation pad 56a is generally similar to the fixation pad of FIG. 1 (i.e., having a pair of opposing crescents 64a, 66a, the recessed portion 116 of which faces the clip 48a at the end of the pad 56a). However, in the particular shape of the fixed pad 56a, its opposing crescents 64a, 66a are not as sharp and the recessed areas 116 are not so clear. This shape provides sufficient contact area to provide greater stability and adhesion to the patient's skin. Further, the dimensions of the fixing pad 56a are not substantially similar to the dimensions and the shape of the release liner 68a, and are not configured as such. That is, the release liner 68a covers the bonding lower layer 58a and the recessed region 116 of the fixing pad 56a.

FIG. 10A shows a particular advantageous embodiment of the fixation system 10a. The fixation system 10a uses a first retaining member with a pair of posts 30a, one post having a relatively blunt end 37a and a tapered angled extension 1a.
Head 3 having a fixed portion with a head 34a having an angled extension with a relatively rounded end 100 and a head 3a having a relatively rounded end 100.
It has a fixed part with 4a. According to this combination, the healthcare professional first requires the catheter fitting 14 through the angled extension 102 of the post 30a.
By aligning one hole 74a of a with the head 34a and then with the shaft 32a, the catheter fitting 14a can be easily connected to the holding device 20a. The other hole 74a of the catheter fitting 14a can then be aligned with the other post 30a (without the angled extension 102). The other hole 74a has a rounded end 100, the other shank 32a has a blunt end 37a, or a further fixing hole 74a.
It can be more easily fitted to the other shaft 32a than if it had an extension 102 angled in the opposite direction to a. Thus, with this synergistic shape, the holes 74a are easily fitted to both posts 30a, and both posts 30a will have a securing portion that prevents catheter misalignment. The illustrated fixation system also includes a second retaining member embodied as a clip 48a, which may be about one axial height of the catheter 12a.
/ 2 hook portion 52a, the entrance 112 to the clip interior (accommodating portion) 114
Are narrowed in the cross axis direction.

FIG. 10B shows another particular advantageous embodiment of the fixation system 10 a, which uses a first retaining member combination with a pair of posts 30 a, one of which is a comparison post. It has a fixed portion with a blunt end 106 and a bulb 104 with a curved extension 110, while the other post 30a has a curved extension with a relatively rounded end 108. It has a fixed part with no spherical part 104. Similar to the embodiment of FIG. 10A, according to this combination, the medical practitioner first aligns one hole 74a of catheter fitting 14a with bulb 104 through curved extension 110 and then with shaft 32a. Thereby, the catheter 12a can be easily connected to the holding device 20a. Then, the other hole 74a of the catheter fitting 14a is inserted into the other post 30a.
(Without the curved extension 110). The other hole 74a has a blunt end 108, the other shaft 32a has a blunt end 106, or a further curved extension directed in the opposite direction to the fixing hole 74a. This other shaft portion 32 is easier than having the other shaft portion 110.
can be adjusted to a. Therefore, the hole 74a
Are easily fitted to both posts 30a, and both posts 30a will have fixed portions that prevent the catheter from slipping. The illustrated fixing system 10a comprises:
Also provided is a second retaining member embodied as a clip 48a without the hook portion 52a, so that the transverse height of the inlet 112 is not reduced toward the clip interior 114.

Accordingly, the fixation system of the present invention provides a sterile, tightly grasping, needle-free and tape-free method for securing a catheter to a patient. This eliminates the use of tape in the retaining device 20 and eliminates accidental needle punctures, suture wound site infections, and scarring if conventional protocols require suturing. Further, retention device 20 can be configured for use with any of a wide variety of catheters 12, fittings 14, tubes, wires, and other medical articles. By using the fixation system of the present invention, patient comfort is also increased and attachment time is reduced.

Although the invention has been described with reference to certain preferred embodiments and further suggested variations thereon, other embodiments and variations apparent to those skilled in the art are also within the scope of the invention. . It is also understood that various aspects of one or several embodiments can be used with another or some embodiments. It is further understood that not all aspects or elements described in connection with a particular embodiment need necessarily be utilized in connection with that embodiment or another embodiment. Accordingly, the scope of the present invention is intended to be defined solely by the appended claims.

[Brief description of the drawings]

FIG. 1 is a perspective view of an anchoring system according to a preferred embodiment of the present invention, showing an exemplary catheter positioned above the anchoring system.

2a is a perspective view of a holding device of the fixing system of FIG. 1;

2b is a perspective view of another embodiment of a retaining device that can be used with a securing system similar to the securing system of FIG.

FIG. 3a is a front view of the holding device of FIG. 2a.

FIG. 3b is a front view of the holding device of FIG. 2b.

FIG. 4a is a side view of the holding device of FIG. 3a.

FIG. 4b is a side view of the holding device of FIG. 3b.

FIG. 5 is a bottom view of the fixing pad of FIG. 1;

FIG. 6 is a top view of the fixation system of FIG. 1 with the catheter fitting positioned above the retaining device.

FIG. 7 is a perspective view of the fixation system of FIG. 1 with the catheter fitting partially engaged with the retention device.

FIG. 8 is a perspective view of the fixation system of FIG. 1 with the catheter fitting fully engaged with the retaining device.

FIG. 9 is a perspective view of an anchoring system according to another preferred embodiment of the present invention, showing an exemplary catheter positioned above the anchoring system.

10A is a perspective view of a holding device of the fixing system of FIG. 9;

10B is a perspective view of another embodiment of a retaining device that can be used with a securing system similar to the securing system of FIG.

[Procedural Amendment] Submission of translation of Article 34 Amendment of the Patent Cooperation Treaty

[Submission date] September 25, 2000 (2000.9.25)

[Procedure amendment 1]

[Document name to be amended] Statement

[Correction target item name] Claims

[Correction method] Change

[Correction contents]

[Claims]

21. comprising the holding device a second post, said two posts, with a shaft portion extending from said base attached to said base, said two posts, and a portion of the medical article Dimensions and shapes are determined to allow engagement with the shaft and to prevent unintentional detachment of a portion of the medical article from the engaged shaft. The fixation system according to claim 1 , comprising a fixation portion formed.

Claims22The fixed portion of each post includes a head, and
At least a portion has an edge dimension that is greater than the edge dimension of the corresponding shaft. 21 The fixation system according to 1.

23. The fixation system of claim 22 , wherein one of the posts has a head further comprising a portion extending radially in a direction opposite to a head of the other post.

24. The extended portion is fixed system of claim 23 which is bent towards the base of the holding device.

25. The fixation system of claim 24 , wherein the extended portion has a taper toward an outer end of the extended portion.

26. At least one of the posts, but distal of the holding device,
23. The fixation system of claim 22 , comprising a head with a blunt, rounded end.

For the medical article 27. engaged in engaged state is prevented from leaving unintentionally from the post, said at least a portion of each head, according to claim 22 having a generally planar rear surface Fixing system.

Claims28A fixed portion of each of the posts has a spherical portion, and the number of the spherical portion is small.
At least a portion has an edge dimension that is greater than the edge dimension of the corresponding shaft. 21 The fixation system according to 1.

29. The fixation system of claim 28 one of said posts, the spherical portion of the other post having further comprising spherical portion portions extending radially in opposite directions.

30. The extended portion forms a hook with a bend toward the base of the holding device and with a taper toward an outer end of the extended portion, the hook further comprising the medical device. 30. The fixation system of claim 29 , which assists in the engagement of an article with the post and prevents the medical article from unintentionally disengaging from the engaged clip.

31. In order to prevent the said medical article is released unintentionally from the clip in the engaged state, the clip is, narrowing the entrance to the clip interior extends towards the holding device fixing system according to claim 1 having a hook portion.

32. The hook portion, the medical claim and is configured so as to narrow the inlet to transverse direction of height less than 3 of the height of the quarter of the engagement portion of the article 3
2. The fixing system according to 1 .

33. The hook portion, the medical claim engagement portion is configured so as to narrow the inlet to the first height of about 2 minutes in the transverse direction of the height of the article 32
The fixing system according to claim 1.

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Claims (36)

[Claims] 1. A catheter introduction system for securing an elongated medical article to a patient, the catheter introduction system having a first surface and a second surface, the adhesive layer covering at least a portion of the second surface. And a base mounted on the first surface of the fixation pad for receiving a portion of the medical article, the base being mounted on the first surface, and at least one extending from the base. And a holding device provided on the post with a fixed portion disposed toward the outer end of the post, and formed on the holding device and engaged with at least a part of the medical article. And at least one clip sized and shaped to perform. 2. The holding device comprises a plurality of posts, each post having a shaft attached to the base and extending from the base, wherein the fixed portion comprises a portion of the medical article and the shaft. And the size and shape are determined so as to prevent the medical article from being unintentionally detached from the shaft part after the engagement. The fixation system according to claim 1. 3. The fixed portion of each post comprises a head, at least a portion of the head having an edge dimension greater than an edge dimension of a corresponding shaft.
The fixing system according to claim 1. 4. The fixing system according to claim 3, wherein the outer circumference of the head is longer than the outer circumference of the shaft. 5. The securing system according to claim 2, wherein the securing portion of the at least one post comprises a hook portion. 6. The fixation system of claim 5, wherein the hook portion is spaced from the shaft. 7. The fixation system of claim 2, wherein the at least two posts are spaced between the posts by a distance sufficient to accommodate at least a portion of the elongated medical article. 8. The fixation system of claim 7, wherein the clips are spaced from each of the posts. 9. The fixation system according to claim 8, wherein the clip is disposed on a line that substantially bisects a line connecting the two posts. 10. The fixation system of claim 1, wherein the base, post, and clip are integrally formed. 11. A fixation system for securing an elongated medical article to a patient, the medical article comprising at least one opening, the fixation system comprising: a fixation pad and a holding device attached to the fixation pad. Wherein the holding device comprises a first holding member and a second holding member, wherein the first holding member is disposed substantially upright with respect to the fixing pad, and a corresponding one of the medical articles The second holding member is configured to be inserted through the opening, and the second holding member is arranged so that at least a part thereof is substantially perpendicular to the first holding member. A fixation spaced from the fixation pad a distance dimensioned to allow at least a portion of the elongated medical article to be disposed between a portion of a member and the fixation pad Stem. 12. The first holding member engages a portion of the medical article with the opening such that unintentional detachment of the medical article from the first holding member is prevented. The fixing system according to claim 11, comprising: 13. A part of the elongated medical article, wherein the second holding member is received at an insertion position between a part of the second holding member and the fixing pad, is extruded from the insertion position. 12. The fixation system according to claim 11, comprising means for blocking 14. The fixation system according to claim 11, wherein the holding device comprises a third holding member disposed substantially at right angles to the second holding member. 15. The fixation system according to claim 14, wherein the third holding member is disposed substantially parallel to the first holding member. 16. The securing system according to claim 15, wherein each of the first and third retaining members includes a post having a shank and a securing portion. 17. The post of claim 16, wherein the fixed portion of each post comprises a hook-shaped portion extending toward the fixed pad, the hook-shaped portion being spaced from the post. Fixed system. 18. The fixation system according to claim 11, wherein the holding device comprises a third holding member disposed substantially parallel to the second holding member. 19. The fixation system of claim 11, further comprising an elongated medical article, wherein the opening is formed in a wing portion of the medical article. 20. The blade according to claim 1, wherein the blade portion is formed of a deformable material.
10. The fixation system according to 9. 21. A method of securing a medical article to a patient's body, wherein the medical article includes an elongated body with flexible wings extending from the body, each wing including at least one suture hole. A method, comprising: providing a retaining device having at least first and second spaced apart posts and a clip positioned on a side of the post, wherein one of the holes for sutures is provided. Inserting the first post, extending the wings to position another suture hole on the second post, inserting the second post into the corresponding suture hole, and inserting the second post into the corresponding suture hole. And inserting a section of the elongate body into the clip such that detachment of the elongate body from the clip is prevented. 22. The method of claim 2, further comprising bonding the holding device to the patient.
2. The method according to 1. 23. An anchoring system for anchoring a catheter to a patient, the anchoring pad having a first surface and a second surface, and mounting on the first surface of the anchoring pad to receive a portion of the catheter. A retainer having a base attached to the first surface and a plurality of posts extending from the base, the retainer being formed on the retainer and engaging at least a portion of a catheter fitting. At least one clip sized and configured to mate. 24. The holding device comprises two posts, each post having a shaft attached to and extending from the base, each post comprising a portion of the catheter and the shaft. The catheter is sized and shaped to allow engagement with a portion of the catheter and to prevent unintentional disengagement of a portion of the catheter from the engaged shaft. 24. The fixation system of claim 23, comprising a fixation portion. 25. The fixation system of claim 24, wherein the fixation portion of each post comprises a head, at least a portion of the head having an edge dimension greater than a corresponding edge dimension of the shaft. 26. The fixation system of claim 25, wherein one of the posts has a head further comprising a portion extending radially in a direction opposite to a head of the other post. 27. The fixation system of claim 26, wherein the extending portion bends toward a base of the retaining device. 28. The fixation system of claim 27, wherein the extended portion has a taper toward an outer end of the extended portion. 29. At least one of said posts, distal to said holding device,
26. The fixation system of claim 25, comprising a head with a blunt rounded end. 30. The head of claim 25, wherein at least a portion of each of the heads has a generally flat back surface to prevent unintentional disengagement of the engaged fixture from the post. Fixing system. 31. The fixation system of claim 24, wherein the fixation portion of each post comprises a sphere, at least a portion of the sphere having an edge dimension greater than an edge dimension of the corresponding shaft. . 32. The fixation system of claim 31, wherein one of the posts has a bulb further comprising a portion extending radially in a direction opposite to the bulb of the other post. 33. The extended portion curves toward the base of the holding device and forms a hook with a taper towards an outer end of the extended portion, the hook further comprising the mounting portion. 33. The securing system of claim 32, which assists in engaging a tool with the post and prevents the fixture from unintentionally disengaging from the engaged clip. 34. The clip extends toward the retaining device and narrows the entrance to the interior of the clip to prevent the fixture from unintentionally disengaging from the engaged clip. 24. The fixation system of claim 23, comprising a hook portion. 35. The fixation system of claim 34, wherein the hook portion is configured to narrow the inlet to a height of less than three quarters of the transverse height of the catheter fitting. 36. The hook portion is configured to narrow the inlet to a height of about one-half the transverse height of the catheter fitting.
The fixing system according to claim 1.